Ignite Creation Date:
2025-12-24 @ 5:43 PM
Ignite Modification Date:
2026-01-04 @ 6:13 AM
Study NCT ID:
NCT04088968
Status:
RECRUITING
Last Update Posted:
2024-03-22
First Post:
2019-07-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
STRONG for Surgery & Strong for Life - Against All Odds: Intensive Prehabilitation for Risk Reduction in Cancer Surgery
Sponsor:
Bispebjerg Hospital
Organization:
Study Overview
Official Title:
STRONG for Surgery & Strong for Life - Against All Odds: Intensive Prehabilitation Including Smoking, Nutrition, Alcohol and Physical Activity for Risk Reduction in Cancer Surgery
Status:
RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
STRONG-CS
Brief Summary:
Despite knowledge about the effect of preventive measures in lifestyle, smoking,nutrition, alcohol and physical activity (SNAP), there is a lack of systematic assessment of the overall lifestyle of the patient before surgery and knowledge about how lifestyle interventions can be organized in connection with cancer surgery. The intention with prehabilitation is to optimize the individual's risk factors and personal burdens that can affect the clinical and patient reported outcomes after surgery. The aim of this study is to evaluate the efficacy of intensive SNAP interventions compared to treatment as usual (TAU) in ptt undergoing urological cancer surgery on surgical risk reduction.
Detailed Description:
The project contains three clinical intervention studies, in total including 100 urological cancer patients screened positive for at least 1 SNAP factor:
I. Efficacy and preferences of intensive SNAP-Interventions among patients with at least one SNAP factor and undertaking neo-adjuvant chemotherapy before radical cystectomy. A randomised controlled trial with nested interviews (42 patients).
II. Implementation and preferences of intensive SNAP-Interventions among patients with kidney cancer undergoing nephrectomy/partial nephrectomy. An implementation feasibility study including interviews (20 patients).
III. Reach out and effect as well as preferences of perioperative intensive smoking cessation intervention via the municipality clinic compared to the surgical department among smokers with non-invasive bladder cancer treated with Trans-Urethral Resection of the Bladder (TUR-B). A randomised controlled trial with nested interviews (38 patients).
The intervention groups receive minimum five educational sessions tailored to individual needs over six weeks perioperatively. The control groups receive standard care.
I. Efficacy and preferences of intensive SNAP-Interventions among patients with at least one SNAP factor and undertaking neo-adjuvant chemotherapy before radical cystectomy. A randomised controlled trial with nested interviews (42 patients).
II. Implementation and preferences of intensive SNAP-Interventions among patients with kidney cancer undergoing nephrectomy/partial nephrectomy. An implementation feasibility study including interviews (20 patients).
III. Reach out and effect as well as preferences of perioperative intensive smoking cessation intervention via the municipality clinic compared to the surgical department among smokers with non-invasive bladder cancer treated with Trans-Urethral Resection of the Bladder (TUR-B). A randomised controlled trial with nested interviews (38 patients).
The intervention groups receive minimum five educational sessions tailored to individual needs over six weeks perioperatively. The control groups receive standard care.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: